DiaMedica Therapeutics Q1 2025 Earnings Report

DiaMedica Therapeutics EPS Results

• Actual EPS: -$0.18
• Consensus EPS: -$0.18
• Beat/Miss: Met Expectations
• One Year Ago EPS: -$0.14

DiaMedica Therapeutics Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

DiaMedica Therapeutics Announcement Details

• Quarter: Q1 2025
• Date: 5/13/2025
• Time: After Market Closes
• Conference Call Date: Wednesday, May 14, 2025
• Conference Call Time: 8:00AM ET

DiaMedica Therapeutics (NASDAQ:DMAC) Inc., a clinical stage biopharmaceutical company, focuses on improving the lives of people suffering from serious diseases with a focus on acute ischemic stroke. Its lead candidate is DM199, a pharmaceutically active recombinant form of the human tissue kallikrein-1 protein, which is in Phase II/III trials for the treatment of acute ischemic stroke, as well as that is in Phase 2 to treat cardio-renal disease. The company also develops DM300, which is in preclinical stage for the treatment of severe inflammatory diseases. In addition, it develops treatment for neurological disease. The company was formerly known as DiaMedica Inc. and changed its name to DiaMedica Therapeutics Inc. in December 2016. DiaMedica Therapeutics Inc. was incorporated in 2000 and is headquartered in Minneapolis, Minnesota.

DiaMedica Therapeutics Q1 2025 Earnings Call Transcript

Key Takeaways

• We are nearing dose selection for Part 1a of our Phase 2 preeclampsia trial, with topline data on safety, blood pressure reductions and placental transfer expected between late June and July.
• Stroke trial enrollment has reached 20–25% of the interim analysis target, and with improved site engagement we expect the interim readout on the first 200 participants in H1 2026.
• As of March 31, 2025 we held $37.3 million in cash and investments, with a projected runway into Q3 2026 after a Q1 operating cash burn of $7.1 million.
• First quarter R&D expenses rose to $5.7 million from $3.7 million a year ago, reflecting REMEDY 2 trial expansion and manufacturing costs, with further moderate increases anticipated.
• DiaMedica is holding a preeclampsia KOL call on May 28 to educate investors and physicians, highlighting DM199 as the only novel agent currently studied in pregnant women with preeclampsia.

Presentation

[Operator]

Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics First Quarter twenty twenty five Conference Call. An audio recording of the webcast will be available shortly after the call today on DiaMedica's website at www.diamedica.com in the Investor Relations section. Before DiaMedica proceeds with its remarks, please note that the company will be making forward looking statements on today's call. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these statements. More information, including factors that could cause actual results to differ from projected results, appears in the section entitled Cautionary Note Regarding Forward Looking Statements in the company's press release issued yesterday and under the heading Risk Factors in the company's most recent annual report on Form 10 ks and most recent quarterly report Form 10 Q.

[Operator]

DiaMedica's SEC filings are available on the SEC's website, www.sec.gov, and on its website, DiaMedica.com. Please also note that any comments made on today's call speak only as of today, 05/14/2025, and may no longer be accurate at the time of any replay or transcript rereading. DiaMedica disclaims any duty to update its forward looking statements. Following the prepared remarks, the phone lines will be open for questions. I would now like to turn you over to your host for today's call, Mr. Rick Pauls, DiaMedica's President and Chief Executive Officer. Mr. Pauls?

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

Thank you, operator. Hello, everyone, and welcome to our first quarter twenty twenty five conference call. I am joined this morning by Scott Kellen, our Chief Financial Officer. Doctor. Lorianne Mascioka is currently on short term medical leave and we hope she gets well soon.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

We're happy to be here today to update you on the progress on our two clinical development programs. It has only been a short interval since our last update, thus I will keep my remarks brief. That said, I'm pleased to report that we continue to make substantial progress in both of our clinical development programs. I'll start with an update on our preeclampsia program. Building upon the significant accomplishments of this program within a very short timeframe, as we discussed in March, we're pleased to be able to disclose that we believe Part 1a of our Phase two investigator sponsored preclampsia trial is very close to identifying a target dose, to move forward within in Part 1b.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

Dose selection will be guided primarily by a few key data points, which we expect to be sharing in our upcoming preliminary top line results from the Part 1a proof of concept portion of the trial. These key data points include: one, safety and tolerability, including results of a placental transfer analysis Two, the amount of decrease in systolic and diastolic blood pressure levels. And three, changes in uterine and placental blood flow as assessed by the Doppler ultrasound measurement of the Uterine Artery Pulcability Index. This measure is important as reductions in the pulsatility index may suggest decreased downstream resistance and improved uterine and placental blood flow, which could also be an indication of disease modifying. Currently we expect to be in a position to release those preliminary top line results between the second half of June and the July.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

The final timing will be primarily dependent on the schedules at the outside laboratories running the various tests, including the pharmacodynamic biomarkers and the assay, which will be used to determine if DM199 crosses the placental barrier. One additional update. May is preeclampsia awareness month, and we will be sponsoring a preeclampsia key opinion leader call on May 28 at 8AM Eastern. Compared to other therapeutic areas like oncology, which have advanced more rapidly in recent years, the treatment of pregnancy complications remains outdated and is not well understood. No FDA approved treatments exist for preeclampsia despite the growing burden of this disease.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

To our knowledge, DM199 is the only novel agent currently being studied in pregnant women with preeclampsia. With this KOL event, we will continue our work to educate investors, physicians, and other interested parties on preeclampsia as a disease and the current state of treatment. With this background, we will also discuss the design of our current Phase two trial of DM199 in preeclampsia. Turning briefly to our stroke program. Enrollment is moving ahead steadily.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

We're pleased to announce that participant enrollment now is between the twentieth and twenty fifth percentile mark of patients enrolled for the interim analysis. Our next enrollment update will be at the fiftieth percentile mark. We believe that our efforts over the past year to engage with sites to promote communications between the sites and to simplify study logistics have been important in driving the recent uptick in enrollment. Accordingly, we reiterated our guidance that the interim analysis on those first two hundred participants will be completed in the first half of twenty twenty six. I would also note for you that we have engaged an experienced stroke neurologist to support site engagement during Lori Ann's leave in order to maintain our enrollment momentum in the REMEDY two trial.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

This individual has spent over ten years treating stroke patients at a major US research center and also has five years of recent biotech drug development experience. He has been doing a tremendous job connecting with and maintaining our relationships with sites and supporting our recent enrollment momentum. Now I'd like to hand the call over to Scott Kellen to review this quarter's financial results.

[Scott Kellen, CFO & Secretary at DiaMedica Therapeutics]

Thanks Rick, and good morning everyone. As the operator mentioned, we announced our first quarter twenty twenty five financial results and filed our quarterly report on Form 10 Q yesterday after the markets closed. These documents are both available on either the DiaMedica or the SEC websites. As of 03/31/2025, we reported a total combined cash and investments of 37,300,000.0 current liabilities of $4,700,000 and working capital of $32,800,000 This compares to a total combined cash and investments of $44,100,000 5 point 4 million dollars in current liabilities and $39,200,000 in working capital as of 12/31/2024. The decreases in combined cash and investments and in working capital were due primarily to the net cash used to fund our operations.

[Scott Kellen, CFO & Secretary at DiaMedica Therapeutics]

Our net cash used in operating activities for the first quarter of twenty twenty five was $7,100,000 compared to $6,700,000 for the first quarter of twenty twenty four. The increase in cash used in operating activities resulted primarily from our increased net loss, partially offset by changes in operating assets abilities occurring during the current year period. We anticipate that our current cash and investments provides us a runway into Q3 of twenty twenty six. Our research and development expenses increased to $5,700,000 for the three months ended 03/31/2025, up from 3,700,000.0 for the three months ended 03/31/2024. The increase was due primarily to cost increases resulting from the continuation of our REMEDY two clinical trial, including our global expansion, increased manufacturing development activity, and the expansion of our clinical team during 2024.

[Scott Kellen, CFO & Secretary at DiaMedica Therapeutics]

Now these increases were partially offset by cost reductions related to in use study work performed and completed in the prior year period. We expect that our R and D expenses will moderately increase in future periods relative to our recent prior periods, as we continue our REMEDY two trial, including the global expansion and our continued expansion of our DM199 clinical development program in preeclampsia. Our general and administrative expenses were $2,500,000 and $2,100,000 for the three months ended 03/31/2025 and 2024 respectively. This increase resulted primarily from additional non cash share based compensation expense recognized as a result of the approval of an extension of the post termination exercise period for stock options held by a retiring member of our Board of Directors. We expect G and A expenses to remain steady in future periods as compared to recent prior periods.

[Scott Kellen, CFO & Secretary at DiaMedica Therapeutics]

Our net other income was $443,000 for the three months ended 03/31/2025, compared to 597,000 for the three months ended 03/31/2024. This decrease was driven by reduced interest income recognized during the current year period related to lower average marketable securities balances during the current year period as compared to the prior year period. With that, let me ask the operator to open the lines for questions.

[Operator]

Thank you so much. Ladies and gentlemen, we will now begin our question and answer session. And And your first question comes from Thomas Flaten with Lake Street. Please go ahead.

[Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets, LLC]

Good morning. I appreciate taking the questions. Hey Rick, just to clarify, the laboratory test results that seem to be the variable in terms of readout between June and July. Is that primarily the test for DM199 crossing the placental barrier so in the umbilical cord or is there something else there that we should be aware of?

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

Yes, Thomas. Yes, absolutely. So that's the main item is going to be the placental transfer. So we have an assay that we're just having finalized in terms of getting to lower limits of detection. And so it's just a question of time for them to run it.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

We want to at least give a range today in terms of when we anticipate the results.

[Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets, LLC]

Makes sense. And then I see you mentioned that you're expecting to start Part 1b in Q3. What are the triggers for Part two and three? So the expected management and the fetal growth restriction components of the study.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

So I'll start off with the fetal growth restriction. So if we see dilation of the intrauterine arteries, our investigators are prepared to move ahead with that cohort and then we'll have more to talk about the part two when we daylight the results here in the coming weeks.

[Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets, LLC]

Got it. Excellent. I appreciate you taking the questions. Thank you.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

Thanks Thomas.

[Operator]

Your next question comes from Matthew Caulfield with H. C. Wainwright. Please go ahead.

[Matthew Caufield, VP - Senior Healthcare Analyst at H.C. Wainwright & Co.]

Hi, good morning, guys. Thanks for taking our question. I was wondering if you could speak to anticipated read through or any derisking between the initial preeclampsia data and how that profile could translate to AIS development and the REMEDY two trial? Thanks again.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

Sure. I mean, I'll start off by saying that these are definitely two very unique indications, but will add that a positive effect here in preeclampsia will just be another confirmation that this protein is active. And I would also mention around that we've previously talked about the fact that there are two forms of this protein in Asia that are being used. So the form of the protein isolated from human urine that today is treating close to a million patients per year for acute ischemic stroke. And then there's also form the protein isolate from pig pancreas in both Japan and China.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

And we've been able to track down about 10 publications with that form of the protein to treat preeclampsia. So I think it will just be very encouraged and that we have an active protein and what we're seeing in some of the validation rationale for going into both of these indications is the, what we'll call the crude forms in Asia today.

[Matthew Caufield, VP - Senior Healthcare Analyst at H.C. Wainwright & Co.]

Thanks a lot. Appreciate guys.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

Thank you.

[Operator]

Your next question comes from Chase Knickerbocker with Craig Hallum. Please go ahead.

[Chase Knickerbocker, Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC]

Good morning. Thanks for taking the questions. Rick, just on stroke, be good to kinda get some incremental details on, on enrollment. I mean, maybe just kinda starting out with those high volume or potential high volume centers. You know, can you kinda give us an update on what percentage of kind of those high volume accounts are now, at that one to two per month that you want to see?

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

I would add that as we had kind of talked on past calls, we really did think that there would be a small number of sites in particular in The U. S. That would drive enrollment. And as we're starting to build some momentum that's clearly what we're starting to see. So some of these high enrolling sites are seeing the one to two patients per site per month.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

And so we're working on building momentum and then really working hard on some of those other sites to expand the relationship here to encourage. But I say currently we are above our plan here now and we're encouraged with momentum that's being built.

[Chase Knickerbocker, Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC]

So maybe just an update on overall centers as well as, know, again, it's only been a couple months here, have we expanded that past 30? Then maybe on the geographic footprint of those centers, have we started to see some international enrollment come in?

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

Yes. So we're currently in mid-30s and keeping in mind that there are sites now that are not performing that we're shutting down. And so we're really again focusing on the high enrolling sites. We also have sites in Georgia that have been performing very well. That's where that is the country of Georgia.

[Chase Knickerbocker, Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC]

Yeah, yeah, got it. And just kind of I guess summon all this up. First half twenty six interim analysis, I think at least implies that enrollment rates continue to pick up. And I mean, you're seeing that trajectory in recent weeks, recent months as far as that curve continuing to steepen?

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

Yes, absolutely. And from the last earnings call, we're definitely seeing an encouraging uptick.

[Chase Knickerbocker, Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC]

Got it. That's it for me. Thanks.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

Great. Thanks, Chase.

[Operator]

Your next question comes from Thomas Flaten with Lake Street. Please go ahead.

[Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets, LLC]

Yes. Hey, thanks for taking another question. Just back to preeclampsia real quick. The Part two and three, those are those studies will be primarily based out of South Africa or are you thinking that there's going to be a U. S. Component of those which would necessitate IND filing?

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

So part, the parts two and part three are still part of the same protocol. And so our collaborators will not need to go back for regulatory clearance.

[Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets, LLC]

And at some point will you expand the study and if so when into The U. S?

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

We do plan in the future to expand this to The U. S. And global and we'll more to share at a later date. Right now again the focus is you're getting the Part 1a and then moving into Part 1b as well as Parts two and then three hopefully.

[Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets, LLC]

Got it. Appreciate it. Thank you.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

Yes. Thanks, Thomas.

[Operator]

Thank you. There are no further questions at this time. I would like to turn the call back to Mr. Rick Puls.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

All right. In closing, we're very encouraged by our steady progress and clear momentum across both the preeclampsia and stroke programs. We look forward to sharing upcoming key milestones including the top line results from our preeclampsia proof of concept trial and the interim analysis from our stroke program. We thank our dedicated team, investigators and importantly our patients and their families for the continued trust and commitment. Please also mark your calendars from May 28 at eight a.

[Rick Pauls, President and Chief Executive Officer at DiaMedica Therapeutics]

M. Eastern Time for our preeclampsia KOL event. We'll be sending out the call in details via press release early next week. As always, we appreciate the ongoing support of our shareholders and look forward to updating you further in the months ahead. Thank you again for joining our call today. This concludes our call.

[Operator]

Ladies and gentlemen, you may now disconnect.

Participants

Executives

• Rick Pauls, President and Chief Executive Officer
• Scott Kellen, CFO & Secretary

Analysts

• Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets, LLC
• Matthew Caufield, VP - Senior Healthcare Analyst at H.C. Wainwright & Co.
• Chase Knickerbocker, Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC